Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Leap Therapeutics DKN-01 gets FDA fast track designation for gastric and gastroesophageal junction cancer

The FDA granted Leap Therapeutics’ (NASDAQ:LPTX) DKN-01 fast track designation for gastric and gastroesophageal junction cancer. Specifically, the designation was granted for patients whose tumors express high Dickkopf...

September 24, 2020

Developments

Mereo setrusumab gets FDA rare pediatric disease designation for osteogenesis imperfecta

The FDA granted Mereo BioPharma’s (NASDAQ:MREO) setrusumab rare pediatric disease designation for the treatment of osteogenesis imperfecta (OI). OI, also known as brittle bone disease, is caused by a genetic mutation in...

September 24, 2020

Developments

Applied Therapeutics AT-007 gets FDA rare pediatric disease and orphan drug designations

The FDA granted Applied Therapeutics’ (NASDAQ:APLT) AT-007 rare pediatric disease and orphan drug designations for the treatment of PMM2-congenital disorder of glycosylation (PMM2-CDG). PMM2-CDG is a rare disease caused...

September 24, 2020

Developments

Calithera treats first patient in Phase 2 non-small cell lung cancer trial

Calithera Biosciences (NASDAQ:CALA) treated the first non-small cell lung cancer (NSCLC) patient in its Phase 2 trial evaluating telaglenastat, a glutaminase inhibitor. The trial will enroll some 120 patients with stage...

September 24, 2020

Developments

AC Immune semorinemab fails Phase 2 Alzheimer’s disease trial

AC Immune (NASDAQ:ACIU) reported disappointing topline results from a Phase 2 trial evaluating semorinemab for the treatment of early Alzheimer’s disease (AD). Semorinemab, an anti-tau antibody, did not meet its primary...

September 23, 2020

Developments

Precipio launches HemeScreen AML

Precipio (NASDAQ:PRPO) launched its HemeScreen acute myeloid leukemia (AML) panel, which tests for the presence of mutations in certain genes to help develop a treatment plan for patients. The company noted that AML...

September 22, 2020

Developments

Crinetics gets FDA rare pediatric disease designation for congenital hyperinsulinism

The FDA granted Crinetics Pharmaceuticals’ (NASDAQ:CRNX) CRN04777 rare pediatric disease designation for the treatment of congenital hyperinsulinism. Congenital hyperinsulinism occurs when infants are born with life...

September 21, 2020

Developments

FDA clears Acutus’ AcQMap catheter

The FDA cleared Acutus Medical’s (NASDAQ:AFIB) AcQMap, a 3D mapping and navigation catheter designed to be inserted into the left and right atrium. In addition to cardiac activation mapping, the AcQMap catheter can...

September 17, 2020

Developments

Zynerba Pharma Zygel gets FDA orphan drug designation for 22q deletion syndrome

Zynerba Pharma’s (NASDAQ:ZYNE) Zygel was granted FDA orphan drug designation for the treatment of 22q11.2 deletion syndrome. Also known as DiGeorge syndrome, 22q11.2 deletion syndrome is caused by a deletion of a small...

September 17, 2020

Developments

Hepion CRV431 shows positive activity against SARS-CoV-2 in NIAID study

Hepion Pharmaceuticals’ (NASDAQ:HEPA) CRV431 demonstrated positive activity against SARS-CoV-2 in a preclinical study conducted at the National Institute of Allergy and Infectious Diseases (NIAID). Conducted under...

September 17, 2020

Developments

Arrowhead reports positive interim results from Phase 2 alpha-1 liver disease trial

Arrowhead Pharma (NASDAQ:ARWR) reported positive 24-week data from its Phase 2 clinical study of ARO-AAT for the treatment of alpha-1 antitrypsin deficiency (AATD)-associated liver disease. ARO-ATT is a subcutaneously...

September 16, 2020

Developments

IntelGenx’s two oral psychedelic film deals featured on FiercePharma

FiercePharma featured IntelGenx (TSXV:IGX; OTCQX:IGXT) and its two recent deals for the development of psychedelic oral films. In July and August, the company signed feasibility agreements with Cybin Corp. and ATAI Life...

September 16, 2020

Developments

Aerpio completes enrollment in Phase 2 glaucoma trial

Aerpio Pharma (NASDAQ:ARPO) completed enrollment in its Phase 2 trial evaluating razuprotafib for the treatment of elevated intraocular pressure (IOP). The study enrolled some 195 patients with elevated IOP associated...

September 15, 2020

Developments

Kiniksa mavrilimumab gets FDA orphan drug designation for giant cell arteritis

Kiniksa Pharma’s (NASDAQ:KNSA) mavrilimumab received FDA orphan drug designation for the treatment of giant cell arteritis (GCA). GCA is a chronic inflammatory disease of medium-to-large arteries, which can result in...

September 15, 2020

Developments

Titan Pharma Probuphine commercialization partner inks European distribution agreement

Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine commercialization partner, Molteni, signed an exclusive European distribution agreement with Accord Healthcare Europe for the commercialization of Sixmo, the brand name...

September 15, 2020

Developments

Frequency Therapeutics reports positive results from hearing loss study

Frequency Therapeutics (NASDAQ:FREQ) reported results from its Phase 2a clinical study of FX-322 for the treatment of sensorineural hearing loss (SNHL). The study follows a Phase 1/2 trial that demonstrated...

September 14, 2020

Developments

AVITA enrolls first patient in pivotal vitiligo trial

AVITA Therapeutics (NASDAQ:RCEL) initiated a pivotal study evaluating its RECELL system for the treatment of vitiligo, an autoimmune disease that causes loss of color or pigmentation in the skin. The study will assess...

September 14, 2020

Developments

iBio featured on ABC affiliate

KXXV, an ABC affiliate in Bryan, Texas, published an article on iBio’s (NYSE AMERICAN:IBIO) two COVID-19 vaccine candidates. The company recently reported that it has selected IBIO-201 as its leading candidate for...

September 11, 2020

Developments

Hepion CRV431 featured on The Bio Report podcast

The Bio Report podcast featured Hepion Pharmaceuticals’ (NASDAQ:HEPA) CRV431 for the treatment of non-alcoholic steatohepatitis (NASH), and potentially, COVID-19. “We’ve kicked off our Phase 2 trial in NASH...

September 11, 2020

Developments

VBL Therapeutics enrolls first patients in Phase 2 metastatic colorectal cancer trial

VBL Therapeutics (NASDAQ:VBLT) enrolled the first two patients in its Phase 2 trial evaluating VB-111, in combination with nivolumab, for the treatment of metastatic colorectal cancer. VB-111 is an adenovirus that...

September 10, 2020

Developments

Satsuma Pharma STS101 fails Phase 3 migraine trial

Satsuma Pharmaceuticals (NASDAQ:STSA) reported disappointing topline results from its Phase 3 trial of STS101 for the acute treatment of migraine. STS101 is a drug-device combination of dihydroergotamine mesylate (DHE)...

September 10, 2020

Developments

Precision BioSciences gets FDA fast track designation for second allogeneic CAR-T cell therapy

Precision BioSciences’ (NASDAQ:DTIL) allogeneic chimeric antigen receptor (CAR-T) cell therapy, PBCAR269A, received FDA fast track designation for the treatment of relapsed/refractory multiple myeloma. PBCAR269A...

September 9, 2020

Leap Therapeutics DKN-01 gets FDA fast track designation for gastric and gastroesophageal junction cancer

Mereo setrusumab gets FDA rare pediatric disease designation for osteogenesis imperfecta

Applied Therapeutics AT-007 gets FDA rare pediatric disease and orphan drug designations

Calithera treats first patient in Phase 2 non-small cell lung cancer trial

AC Immune semorinemab fails Phase 2 Alzheimer’s disease trial

Precipio launches HemeScreen AML

Crinetics gets FDA rare pediatric disease designation for congenital hyperinsulinism

FDA clears Acutus’ AcQMap catheter

Zynerba Pharma Zygel gets FDA orphan drug designation for 22q deletion syndrome

Hepion CRV431 shows positive activity against SARS-CoV-2 in NIAID study

Arrowhead reports positive interim results from Phase 2 alpha-1 liver disease trial

IntelGenx’s two oral psychedelic film deals featured on FiercePharma

Aerpio completes enrollment in Phase 2 glaucoma trial

Kiniksa mavrilimumab gets FDA orphan drug designation for giant cell arteritis

Titan Pharma Probuphine commercialization partner inks European distribution agreement

Frequency Therapeutics reports positive results from hearing loss study

AVITA enrolls first patient in pivotal vitiligo trial

iBio featured on ABC affiliate

Hepion CRV431 featured on The Bio Report podcast

VBL Therapeutics enrolls first patients in Phase 2 metastatic colorectal cancer trial

Satsuma Pharma STS101 fails Phase 3 migraine trial

Precision BioSciences gets FDA fast track designation for second allogeneic CAR-T cell therapy

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